EUCTR2010-020681-16-DE进行中（未招募）不适用
A PILOT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF A DAILY DOSE OF 500MG. LU901 (4PHENYL-BUTYRATE, CONTROLLED RELEASE TABLETS) IN ADDITION TO STANDARD HORMONAL TREATMENT IN PATIENTS WITH METASTASIZED PROSTATE CARCINOMA AND A LIFE EXPECTANCY OF AT LEAST 6 MONTHS.
unamed Operations AG0 个研究点开始时间: 2010年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients with a confirmed diagnosis of prostate carcinoma, and measurable metastatic lesion(s).
- •Stage of the disease is T*any*,N*>1* and/or M*>1*, but with a life expectancy of at least 6 months under first-line hormonal treatment.
- •Patient must be at least 21 years of age.
- •Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with life expectancy < 6 months.
- •Patients with hormonal treatment for prostate carcinoma, initiated within 3 months before start of the study.
- •Patients with non-hormonal treatment for their prostate cancer at study entry.
- •Included patients with rapidly progressive disease (based on clinical judgment of the investigator) requiring second-line treatment (e.g. chemo therapy) will drop out of the study. In case of progression within 6 months after entry into the study, the patient will be replaced, in case of progression after 6 months post-entry, the patient will be regarded as treatment failure.
- •Patients participating in another study protocol.
- •Any condition that would limit the ability to receive oral medication.
- •Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- •Active second primary malignancy (except adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.
研究者
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